# Soft tissue sarcoma

The EU has approved 3 indications of 3 drugs in soft tissue sarcoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pazopanib](https://oncolabels.com/drugs/pazopanib) (Votrient) | None | Monotherapy | 2nd line, advanced | After prior chemotherapy for metastatic disease or progression within 12 months after (neo)adjuvant therapy; Selective subtypes of advanced soft-tissue sarcoma |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | None | Monotherapy | Advanced | Dermatofibrosarcoma protuberans only; Not eligible for surgery (for recurrent and/or metastatic DFSP) |
| [Tasonermin](https://oncolabels.com/drugs/tasonermin) (Beromun) | None | + melphalan via mild hyperthermic isolated limb perfusion (ILP) | Advanced | As an adjunct to surgery for subsequent removal of the tumour to prevent or delay amputation, or in the palliative situation |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Imatinib** (Glivec), Soft tissue sarcoma, advanced: “the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Tasonermin** (Beromun), Soft tissue sarcoma, advanced: “Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/beromun-epar-product-information_en.pdf)
- **Pazopanib** (Votrient), Soft tissue sarcoma, 2nd line, advanced: “Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/soft-tissue-sarcoma